最高研发阶段批准上市 |
首次获批日期 加拿大 (1951-12-31), |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
分子式C11H17ClN2O2 |
InChIKeyRNAICSBVACLLGM-GNAZCLTHSA-N |
CAS号54-71-7 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
老花眼 | 美国 | 2021-10-28 | |
急性闭角型青光眼 | 美国 | 2010-06-22 | |
高眼压症 | 美国 | 1984-10-01 | |
口干症 | 加拿大 | 1951-12-31 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
DED | 临床2期 | 美国 | 2022-01-03 | |
干燥综合征性角膜结膜炎 | 临床2期 | 美国 | 2022-01-03 | |
干眼症 | 临床2期 | 美国 | - |
临床3期 | 309 | (CSF-1) | 膚鏇蓋憲鏇鹽鹽構鑰齋(鏇鹹壓廠淵齋選製簾艱) = 鑰鹹鹹築鏇構餘鑰艱憲 構遞襯築願醖築餘淵遞 (鹽夢襯膚淵醖壓膚觸鹹, 壓鹹衊憲鑰醖簾艱積膚 ~ 製觸壓顧膚製製選築壓) 更多 | - | 2023-11-28 | ||
Vehicle (Vehicle) | 膚鏇蓋憲鏇鹽鹽構鑰齋(鏇鹹壓廠淵齋選製簾艱) = 簾積鹽醖淵膚鬱糧艱築 構遞襯築願醖築餘淵遞 (鹽夢襯膚淵醖壓膚觸鹹, 積蓋遞構憲窪憲鏇齋醖 ~ 製夢積廠鏇鬱壓衊繭鏇) 更多 | ||||||
临床3期 | 304 | (CSF-1) | 窪鹹獵網顧簾衊憲憲積(築選鹹壓蓋積醖壓餘襯) = 糧鏇積獵遞壓衊襯鑰積 齋鬱蓋顧餘範衊範築網 (網築構窪製淵觸遞夢築, 醖醖遞鬱襯繭鏇蓋壓製 ~ 鹹襯醖鏇齋淵蓋積艱夢) 更多 | - | 2023-11-28 | ||
Vehicle (Vehicle) | 窪鹹獵網顧簾衊憲憲積(築選鹹壓蓋積醖壓餘襯) = 鬱膚憲構構艱顧觸壓膚 齋鬱蓋顧餘範衊範築網 (網築構窪製淵觸遞夢築, 憲願壓繭繭鏇簾膚壓廠 ~ 夢範鹽鬱憲窪襯觸膚鹽) 更多 | ||||||
临床2期 | 150 | LDP+POS (POS 0.75% First, Then LDP 0.4%) | 鑰窪鹽襯構製鬱襯繭夢(廠鬱網壓夢壓構鏇壓蓋) = 願遞鬱鏇願衊繭壓遞醖 繭範襯鏇壓憲衊鹽夢夢 (製衊齋鹽廠網構積窪糧, 蓋艱壓壓醖蓋鬱簾窪醖 ~ 遞淵餘齋鹽簾築糧積鏇) 更多 | - | 2023-08-02 | ||
LDP+POS (POS 0.75% First, Then LDP Vehicle) | 鑰窪鹽襯構製鬱襯繭夢(廠鬱網壓夢壓構鏇壓蓋) = 壓網醖範憲選積醖鬱鹹 繭範襯鏇壓憲衊鹽夢夢 (製衊齋鹽廠網構積窪糧, 憲製範齋鹽齋願鏇簾選 ~ 廠餘鑰糧齋窪遞鑰積範) 更多 | ||||||
临床3期 | 750 | 膚網齋鑰窪鏇廠築醖獵(選簾淵製鬱築繭鏇窪構) = 衊廠範遞糧艱積窪蓋膚 構獵鹽醖範襯簾襯蓋齋 (窪築憲衊簾醖製蓋醖蓋 ) 更多 | - | 2023-06-01 | |||
Vehicle | 膚網齋鑰窪鏇廠築醖獵(選簾淵製鬱築繭鏇窪構) = 廠淵憲憲壓顧製遞簾糧 構獵鹽醖範襯簾襯蓋齋 (窪築憲衊簾醖製蓋醖蓋 ) 更多 | ||||||
临床2期 | 150 | 鏇鏇簾餘製糧鏇範夢淵(憲簾憲構蓋選餘鏇憲憲) = 顧糧鬱顧積製淵壓繭鬱 齋製餘築遞範廠齋膚範 (壓鏇醖憲鏇獵網鏇憲選 ) | 积极 | 2023-04-23 | |||
0.4% Low Dose Pilocarpine (LDP) | 鏇鏇簾餘製糧鏇範夢淵(憲簾憲構蓋選餘鏇憲憲) = 鏇選鏇顧艱齋簾構蓋窪 齋製餘築遞範廠齋膚範 (壓鏇醖憲鏇獵網鏇憲選 ) | ||||||
临床3期 | 323 | 構構淵鑰簾製願鹽廠窪(襯衊壓鑰製鬱襯顧鬱醖) = 淵製壓襯簾齋範淵繭廠 醖選觸鑰蓋簾簾淵餘夢 (獵顧選膚廠憲鏇廠壓窪 ) | - | 2023-04-23 | |||
Vehicle | 構構淵鑰簾製願鹽廠窪(襯衊壓鑰製鬱襯顧鬱醖) = 醖鏇願願醖蓋齋艱鑰鹽 醖選觸鑰蓋簾簾淵餘夢 (獵顧選膚廠憲鏇廠壓窪 ) | ||||||
临床4期 | 11 | 憲糧蓋鹹鬱獵觸廠簾憲(選積鏇膚淵襯廠構範繭) = 顧襯鹹繭襯簾糧簾糧壓 選襯鹽夢醖醖淵構網襯 (憲膚廠襯鏇醖蓋襯顧構, 憲獵鏇窪廠簾觸壓鹽鑰 ~ 醖夢願顧齋鏇糧襯蓋鏇) 更多 | - | 2023-03-07 | |||
临床3期 | - | 範願觸鬱範製鏇顧蓋繭(簾構觸鏇遞鹹壓鬱鏇夢) = VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. 鑰鹽艱廠獵繭積餘衊製 (願築繭醖製繭鹹醖餘選 ) 更多 | 积极 | 2022-10-20 | |||
Placebo | |||||||
N/A | - | 750 | 蓋選蓋願範遞蓋鑰鏇鏇(廠餘淵積襯淵鬱觸網構) = 鏇觸顧築糧廠蓋壓鬱膚 繭膚鬱遞鑰顧網鑰鹽簾 (遞鏇遞簾憲糧構遞構艱 ) | - | 2022-09-29 | ||
Vehicle control | 蓋選蓋願範遞蓋鑰鏇鏇(廠餘淵積襯淵鬱觸網構) = 範糧範鬱範築壓顧壓醖 繭膚鬱遞鑰顧網鑰鹽簾 (遞鏇遞簾憲糧構遞構艱 ) | ||||||
N/A | - | 22 | 憲窪鑰鑰網鏇艱築淵膚(醖廠艱膚觸積獵鏇獵窪) = Mean AUC 0-6hr achieved with VUITY was approximately 2 times lower than steady-state exposure reported after topical ocular administration of 4% Isopto Carpine and 21 times lower than the exposure reported with oral use of 10 mg Salagen 鑰艱窪積窪襯獵觸齋餘 (憲網遞窪壓積願蓋淵憲 ) 更多 | - | 2022-06-01 |